510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191924Substantially Equivalent

SAFECARE® THC Urine Strip Test

Safecare Biotech(hangzhou)co.,Ltd, Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191924 is the FDA 510(k) clearance record for SAFECARE® THC Urine Strip Test, a class II device, cleared for Safecare Biotech (Hangzhou) Co., Ltd. on under FDA product code NFW (Test, Cannabinoid, Over The Counter). FDA records list 9 510(k) clearances for Safecare Biotech (Hangzhou) Co., Ltd., from to . As of , FDA records show no recalls naming K191924.

Clearance record

Decision date
Received
(29 days to decision)
Product code
NFW Test, Cannabinoid, Over The Counter
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Safecare Biotech (Hangzhou) Co., Ltd. Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFW

Trailing 12 months
1 clearance under product code NFW in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260